Validation of Qualitative Microbiological Methods of Pharmaceutical Analysis

Гунар, О. В.; Буйлова, И. А.

doi:10.1007/s11094-017-1560-0

Cited by 2 publications

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“…(ГФ РФ XIV) 2 для этих целей следует использовать чашечные агаровые методы, мембранную фильтрацию и метод наиболее вероятных чисел. В современных исследованиях, руководствах и нормативных документах в качестве основных параметров валидации количественных тестов рекомендуют использовать «правильность», «прецизионность», «специфичность», «предел количественного определения», «линейность», «рабочий диапазон», «устойчивость» 3 [4][5][6][7][8].…”

Section: оригинальные статьи / Original Articlesunclassified

“…Применимость тех или иных микробиологических методик оценивают при помощи валидационных параметров по критериям приемлемостиэто ожидаемые результаты или заданные значения валидационного параметра, которые применяют для оценки соответствия методики путем сравнения с полученными экспериментальными данными 4 . В связи с большой вариабельностью микробиологических методик критерии приемлемости меняются в сторону увеличения процента отклонения 5 .…”

Section: оригинальные статьи / Original Articlesunclassified

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Validation Parameters as Applied to Methods for Quantification of Microorganisms in Medicinal Products

Буйлова¹,

Гунар²

2020

Vedomosti Nauchnogo tsentra ekspertizy sredstv meditsinskogo pr

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Validation/verification of microbiological methods is a prerequisite for quality control of non-sterile drugs. However, the use of existing procedures for validation/verification of analytical methods is challenging, since a number of factors, such as microorganism distribution in the sample, cell morphology, and metabolic activity of microorganisms contribute to the error in microbiological testing.The aim of the study was to assess the feasibility of using the microbiological method validation parameters for validation/verification of the agar plate method.Materials and methods: 18 non-sterile medicinal products were used in the study. Experiments included determination of antimicrobial activity. The quantification of viable bacteria, yeasts and moulds was performed using the modified pour plate method. The statistical processing of the obtained results was performed using Microsoft Excel 7.0 and Statistica 8.0.Results: the paper provides the results of quantitative determination of test microorganisms inoculated into non-sterile drugs. The results were obtained as part of validation/verification of the agar plate method of the State Pharmacopoeia of the Russian Federation, XIV ed.Conclusions: the validation/verification of the test method for isolation and quantification of microorganisms revealed no deviations of the study results from the established acceptance criteria. This proves the feasibility of using the following validation parameters: accuracy, precision, robustness, and limit of quantitation when validating new methods for quantitative determination of microorganisms or verification of previously validated methods.

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Section: оригинальные статьи / Original Articlesunclassified

Validation Parameters as Applied to Methods for Quantification of Microorganisms in Medicinal Products

Буйлова¹,

Гунар²

2020

Vedomosti Nauchnogo tsentra ekspertizy sredstv meditsinskogo pr

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“…Thus, the problem of microbial contamination of soft DFs does objectively exist. An assessment of drug quality must consider the DF and the nature and method of use [7,8].…”

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Features of Microbiological Analysis of the Quality of Soft Dosage Forms

2021

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Materials related to features of microbiological analysis of the purity of soft dosage forms are presented. Possible requirements for microbiological quality parameters of various soft dosage forms are analyzed. The applicability of a direct inoculation technique to obtain reliable quantitative determinations of microorganisms is proven using gel, ointment, and suppositories as examples. The accuracy (K gr 75 -107%) and intralaboratory precision (CV 2 -6%) are calculated and fall within the required limits. The specificity of the method is considered for a particular working range established according to recommendations of the RF State Pharmacopoeia, i.e., up to 250 CFU/dish for bacteria and up to 50 CFU/dish for yeasts and molds. Features of microbiological analysis of the quality of patches and transdermal therapeutic systems are studied. The possibilities and limitations of a membrane filtration technique are shown using 83 series of 18 items meeting regulatory requirements as examples.

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Validation of Qualitative Microbiological Methods of Pharmaceutical Analysis

Cited by 2 publications

References 1 publication

Validation Parameters as Applied to Methods for Quantification of Microorganisms in Medicinal Products

Validation Parameters as Applied to Methods for Quantification of Microorganisms in Medicinal Products

Features of Microbiological Analysis of the Quality of Soft Dosage Forms

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